Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.64 per share versus the Zacks Consensus Estimate of a loss of $0.69. This compares to loss of $0.81 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 7.25%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.59 per share when it actually produced a loss of $0.54, delivering a surprise of 8.47%.Over the last four quarters, the ...

临床试验进展 - 公司完成了两项针对慢性自发性荨麻疹(CSU)的3期临床试验EMBARQ-CSU1和EMBARQ-CSU2[113] - 公司正在探索冷诱发性荨麻疹(ColdU)和皮肤摩擦性荨麻疹(SD)的1b期临床试验[115][116] - 2期临床试验结果显示barzolvolimab在ColdU和SD患者中达到了主要疗效终点,安全性良好[130][132] - 公司计划推进barzolvolimab在CIndU适应症的3期注册性临床开发[133] - 公司完成了一项针对PN的1b期多中心、随机、双盲、安慰剂对照静脉给药研究[135] - 公司已启动一项针对PN的2期皮下给药研究,正在评估两种剂量水平的barzolvolimab与安慰剂的疗效和安全性[141] 临床疗效和安全性 - 1.5mg/kg和3mg/kg剂量的barzolvolimab在ColdU和SD患者中均取得了快速和持久的临床疗效[118][119] - 3mg/kg剂量的barzolvolimab在56%的胆碱能性荨麻疹(CholU)患者中取得了完全缓解[120] - barzolvolimab治疗可以显著降低血清色素酶和皮肤肥大细胞水平,与临床疗效改善相关[122] - barzolvolimab在ColdU和SD患者中总体安全性良好,常见不良反应包括毛发变色和味觉改变[123][124] - 3.0 mg/kg剂量的barzolvolimab可以快速且持久地减少瘙痒并促进皮肤病变愈合,且barzolvolimab总体耐受性良好[136] - 在3.0 mg/kg剂量组中,有57%的患者在第8周达到WI-NRS评分≥4分的下降,这种疗效一直持续到第16周[137] - 在3.0 mg/kg剂量组中,29%的患者在第8周达到IGA评分0/1(皮肤几乎或完全清洁),这种疗效从第2周开始就已观察到并一直持续到第12/16周[138] - 临床活性与血清色素酶水平的显著降低相关,3.0 mg/kg剂量组色素酶水平降至定量下限或以下,至少持续到第8周[139] - 3.0 mg/kg剂量组在最初8周内出现1例严重不良事件(过敏反应),但最终完全恢复,其他不良事件与PN患者常见的合并症一致[140] 管线拓展 - 公司的新一代双特异性抗体平台正在支持管线的扩展,CDX-622正在开发中并计划于2024年底启动1期临床试验[146,147] - 公司决定不推进CDX-585的开发,而将重点放在炎症领域,包括barzolvolimab的5个适应症研究和CDX-622的临床前进展[148] 财务状况 - 公司通过公开发行9,798,000股普通股筹集到净收益4.323亿美元[178] - 公司投资组合主要包括货币市场基金等短期投资,不存在重大市场风险[179] - 公司不使用衍生金融工具,现金及应收应付账款等金融工具的账面价值接近公允价值[180]

EXHIBIT 99.1 Celldex Reports Third Quarter 2024 Financial Results and Provides Corporate Update Enrollment continues in Phase 3 barzolvolimab CSU studies; Phase 3 program in CIndU under development All primary and secondary endpoints met with high statistical significance in global Phase 2 CIndU study Long term 52 week treatment data in landmark, global Phase 2 CSU study demonstrated deepening of response and a favorable safety profile Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to ...

Enrollment continues in Phase 3 barzolvolimab CSU studies; Phase 3 program in CIndU under developmentAll primary and secondary endpoints met with high statistical significance in global Phase 2 CIndU study Long term 52 week treatment data in landmark, global Phase 2 CSU study demonstrated deepening of response and a favorable safety profile Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to start in Q4  Celldex’s first bispecific for inflammatory diseases, CDX-622, to enter the clinic i ...

文章核心观点 - 公司宣布其研发的barzolvolimab在两种最常见的慢性诱发性荨麻疹(CIndU)——冷性荨麻疹(ColdU)和症状性皮肤白斑(SD)的大型随机安慰剂对照II期临床试验中取得积极结果 [1][3][4] - 该药物是首个在大型随机安慰剂对照试验中证明在CIndU患者中具有临床获益的药物 [3] - 该药物具有良好的安全性和耐受性 [6] - 公司计划将CIndU推进至III期临床开发 [1] 临床试验结果总结 主要疗效指标 - 在ColdU和SD患者中,与安慰剂相比,barzolvolimab治疗组在第12周时出现阴性诱发试验(完全缓解)的患者比例显著更高 [4] - 在ColdU组,150mg每4周和300mg每8周剂量组分别有46.9%和53.1%的患者出现阴性诱发试验,而安慰剂组仅有12.5% [4] - 在SD组,150mg每4周和300mg每8周剂量组分别有57.6%和42.4%的患者出现阴性诱发试验,而安慰剂组仅有3.2% [4] 其他疗效指标 - 在ColdU组,两个剂量组患者的关键温度阈值(CTT)和关键摩擦阈值(CFT)均显著改善 [5] - 在SD组,两个剂量组患者的CFT也显著改善 [5] - 两个剂量组患者的荨麻疹控制测试(UCT)评分均显著改善,反映了疾病控制良好 [5] - 患者在给药2周后即出现快速疾病改善,表现为诱发试验时关键温度和摩擦阈值下降,瘙痒减轻 [5] 安全性 - 该药物总体安全性良好,大部分不良事件为1级(轻度) [6] - 最常见的不良事件为毛发变色(15%)和中性粒细胞减少(10%),这些与药物作用机制相关且预计可逆 [6] - 感染发生率在治疗组和安慰剂组之间无差异,中性粒细胞减少未与感染相关 [6]

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that 12 week results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024. Presenta ...

Shares of Celldex Therapeutics (CLDX) lost 12.1% on Wednesday due to unsatisfactory 52-week safety data from a mid-stage study of its investigational candidate, barzolvolimab, which is being developed for treating chronic spontaneous urticaria (CSU).CSU is a type of skin disease, characterized by the sudden appearance of hives (raised, itchy welts) without an identifiable trigger. The exact cause is often unknown, but it can be linked to immune system dysfunction, where the body mistakenly triggers allergic ...

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Am ...

HAMPTON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in fireside chats at two upcoming conferences: 2024 Cantor Global Healthcare Conference on Tuesday, September 17th at 8:35 a.m. ET TD Cowen's Chronic Urticaria Summit on Friday, September 20th at 10:00 a.m. ET Live webcasts of the presentations will be available on the "Events & Presentations” page of the "Investors & Media" section of the Celldex website. Replays will ...

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to loss of $0.65 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8.47%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.67 per share when it actually produced a loss of $0.56, delivering a surprise of 16.42%.Over the last four quarters, th ...